Medical device and system for occluding a tissue opening and method thereof

ABSTRACT

Devices, methods and systems are provided for occluding a left atrial appendage. In one embodiment, a medical device includes a cover portion and a foam anchor portion with a flexible member coupled therebetween. The cover portion is configured to be positioned over an ostium of the left atrial appendage. The foam anchor portion extends between a proximal end and a distal end to define a length and an axis defined along the length of the foam anchor portion. The foam anchor portion defines a curved external surface radially extending relative to the axis such that the curved external surface extends between the proximal and distal ends of the foam anchor portion. The foam anchor portion is configured to self-expand to provide an outward biasing force from the curved external surface such that a circumferential surface area of the curved external surface biases against tissue of the left atrial appendage.

TECHNICAL FIELD

The present invention relates generally to the occlusion of tissueopenings or appendages and, more specifically, to devices, systems andmethods for occluding or otherwise structurally altering such openingsand appendages including, for example, left atrial appendages.

BACKGROUND

The upper chambers of the heart, the atria, have appendages attached toeach of them. For example, the left atrial appendage is a feature of allhuman hearts. The physiologic function of such appendages is notcompletely understood, but they do act as a filling reservoir during thenormal pumping of the heart. The appendages typically protrude from theatria and cover an external portion of the atria. Atrial appendagesdiffer substantially from one to another. For example, one atrialappendage may be configured as a tapered protrusion while another atrialappendage may be configured as a re-entrant, sock-like hole. The innersurface of an appendage is conventionally trabeculated with cords ofmuscular cardiac tissue traversing its surface with one or multiplelobes.

The atrial appendages appear to be inert while blood is being pumpedthrough them during normal heart function. In other words, theappendages do not appear to have a noticeable effect on blood pumpedthrough them during normal heart function. However, in cases of atrialfibrillation, when the atria go into arrhythmia, blood may pool andthrombose inside of the appendages. Among other things, this can pose astroke risk when it occurs in the left appendage since the thrombus maybe pumped out of the heart and into the cranial circulation once normalsinus rhythm is restored following arrhythmia events.

Historically, appendages have sometimes been modified surgically toreduce the risk imposed by atrial fibrillation. In recent years deviceswhich may be delivered percutaneously into the left atrial appendagehave been introduced. The basic function of these devices is to excludethe volume within the appendage with an implant which then allows bloodwithin the appendage to safely thrombose and then to be graduallyincorporated into cardiac tissue. This process, coupled with the growthof endothelium over the face of the device, can leave a smooth,endothelialized surface where the appendage is located. In comparison tosurgical procedures, devices implanted percutaneously are a lessinvasive means for addressing the problems associated with the leftatrial appendage.

However, due to the wide variability of the ostium size and volume ofthe left atrial appendage, current implantable devices conventionallyinclude a structure that cannot meet such variability, resulting ininadequate devices for many left atrial appendage anatomies. Further,such implantable devices are substantially limited by the orientation bywhich they can successfully be deployed. Even further, another problemwith many of the current implantable devices is that they are anchoredwith hooks of a size and length that often results in perfusion risk tothe patient. As such, it would be advantageous to provide a percutaneoussystem, method and/or device that addresses, for example, the issues ofperfusion risk, implant orientation, the variability in sizes and shapesof the left atrial appendage, or all of these, in order to provide highsuccess in left atrial appendage modification.

A variety of features and advantages will be apparent to those ofordinary skill in the art upon reading the description of variousembodiments set forth below.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to various devices,systems and methods of occluding an opening in the tissue of a body. Forexample, in one embodiment, a medical device for occluding a left atrialappendage of a heart is provided. The medical device includes a coverportion and a foam anchor portion. The cover portion includes a hub anda cover, the cover extending radially from the hub such that the coverportion is sized and configured to be positioned along a proximal sideof an ostium of the left atrial appendage. The foam anchor portion iscoupled to the cover portion with a flexible member. The foam anchorportion extends between a proximal end and a distal end to define alength and an axis, the axis defined along the length of the foam anchorportion. The foam anchor portion defines a curved external surfaceradially extending relative to the axis such that the curved externalsurface extends between the proximal and distal ends of the foam anchorportion. Further, the foam anchor portion is configured to self-expandto provide an outward biasing force from the curved external surfacesuch that a circumferential surface area of the curved external surfacebiases against tissue of the left atrial appendage.

In another embodiment, the curved external surface defines a totalsurface area, and wherein at least half of the total surface area of thecurved external surface is sized and configured to grab and contacttissue within the left atrial appendage. In another embodiment, thecurved external surface of the foam anchor portion includes microprotrusions sized and configured to grab and contact tissue within theleft atrial appendage with the outward biasing force.

In another embodiment, the curved external surface of the foam anchorportion includes a raised grid pattern sized and configured to grabtissue with the outward biasing force. In yet another embodiment, thecurved external surface of the foam anchor portion defines multipleprotrusions sized and configured to grab and anchor to tissue with theoutward biasing force. In still another embodiment, the curved externalsurface of the foam anchor portion defines multiple recesses therein,the multiple recesses defined by raised portions of the curved externalsurface of the foam anchor portion. In another embodiment, the curvedexternal surface of the foam anchor portion defines multiple ring shapedstructures.

In another embodiment, the foam anchor portion expands to a shaperesembling at least one of a truncated cone structure and a cylindricalstructure. In still another embodiment, the foam anchor portion extendswith a variable foam density between a proximal end portion and a distalend portion of the foam anchor portion, the distal end portion having agreater foam density than the proximal end portion. In anotherembodiment, the foam anchor portion includes variable expandabilitybetween a proximal end portion and a distal end portion of the foamanchor portion, the distal end portion having greater expandability thanthe proximal end portion.

In another embodiment, the cover portion extends with a proximal facingsurface having a concave structure, the proximal facing surface facingaway from a distal end of the medical device. In another embodiment,wherein, upon the cover portion and the foam anchor portion beingdeployed, the flexible member is extendable at an angle relative to theaxis of the foam anchor member.

In accordance with another embodiment of the present invention, amedical device system for occluding a left atrial appendage of a heartis provided. The medical device system includes a delivery device and amedical device. The delivery device includes a handle and a catheterextending between a proximal end and a distal end, the proximal endcoupled to the handle, the catheter defining a lumen extendinglongitudinally through the catheter between the proximal and distal endsof the catheter. The medical device is operatively coupled to thehandle. Further, the medical device is sized and configured to be movedbetween a constricted state and an expanded state such that, in theconstricted state, the medical device is within a distal end portion ofthe catheter and, in the expanded state, the medical device is advancedfrom the catheter. The medical device includes a cover portion and afoam anchor portion. The cover portion includes a hub and a cover, thecover extending radially from the hub. The cover portion is sized andconfigured to be positioned along a proximal side of an ostium of theleft atrial appendage. The foam anchor portion is coupled to the coverportion with a flexible member. Further, the foam anchor portion extendsbetween a proximal end and a distal end to define a length and an axis,the axis defined along the length of the foam anchor portion. The foamanchor portion defines a curved external surface radially extendingrelative to the axis such that the curved external surface extendsbetween the proximal and distal ends of the foam anchor portion. Thefoam anchor portion is configured to self-expand to provide an outwardbiasing force along the curved external surface such that acircumferential surface area of the curved external surface biasesagainst tissue of the left atrial appendage.

In another embodiment, the curved external surface defines a totalsurface area, and wherein at least half of the surface area of thecurved external surface is sized and configured to grab and contacttissue within the left atrial appendage with the outward biasing force.In another embodiment, the curved external surface of the foam anchorportion includes micro protrusions sized and configured to grab andcontact tissue within the left atrial appendage with the outward biasingforce. In another embodiment, wherein, upon the cover portion and thefoam anchor portion being deployed, the flexible member is extendable atan angle relative to the axis of the foam anchor member.

In accordance with another embodiment of the present invention, a methodfor occluding a left atrial appendage a heart is provided. The methodsteps include: advancing a medical device with a catheter of a deliverysystem through a vasculature and into the left atrial appendage of theheart, the medical device positioned in a constricted state in a distalend portion of the catheter, the medical device including a coverportion and a foam anchor portion with a flexible member coupledtherebetween, the foam anchor portion having a length extending betweena proximal end and a distal end and the foam anchor portion defining anaxis extending axially along the length; deploying the anchor portion ofthe medical device from the distal end portion of the catheter toself-expand so that a circumferential surface area of a curved externalsurface of the foam anchor portion contacts and lodges against tissuewithin the left atrial appendage with an outward biasing force;deploying the cover portion of the medical device from the distal endportion of the catheter so that the cover portion self-expands to anexpanded state; and cinching the cover portion of the medical deviceagainst an ostium of the left atrial appendage to shorten a length ofthe flexible member coupled between the foam anchor portion and thecover portion.

In another embodiment, the method step of cinching includes tautlyextending the flexible member from the foam anchor portion so that theflexible member extends at an angle relative to the axis of the foamanchor portion. In another embodiment, the method step of deploying theanchor portion includes anchoring the foam anchor portion with thecircumferential banded area of the curved external surface and withmicro protrusions defined along the curved external surface of the foamanchor portion. In still another embodiment, the method step ofdeploying the cover portion includes expanding the cover portion withspokes extending radially from a hub of the cover portion. In anotherembodiment, the method further includes releasing the catheter from themedical device and withdrawing the delivery system from the heart topermanently leave the medical device in the left atrial appendage.

In accordance with another embodiment of the present invention, amedical device for occluding a left atrial appendage of a heart isprovided. The medical device includes a foam anchor extending between aproximal end and a distal end to define a length and an axis definedalong the length of the foam anchor, the foam anchor defining a curvedexternal surface radially extending relative to the axis such that thecurved external surface extends between the proximal and distal ends ofthe foam anchor, the foam anchor configured to self-expand to provide anoutward biasing force from the curved external surface such that acircumferential surface area of the curved external surface biasesagainst tissue of the left atrial appendage.

In another embodiment, the foam anchor extends between the proximal anddistal ends to exhibit at least one of a truncated cone structure and acylindrical structure. In another embodiment, the curved externalsurface defines a total surface area, and wherein at least half of thetotal surface area of the curved external surface is sized andconfigured to grab and contact tissue within the left atrial appendage.In another embodiment, the curved external surface of the foam anchorportion includes micro protrusions sized and configured to grab andcontact tissue within the left atrial appendage with the outward biasingforce.

In another embodiment, the curved external surface of the foam anchorportion includes a raised grid pattern sized and configured to grabtissue with the outward biasing force. In yet another embodiment, thecurved external surface of the foam anchor portion defines multipleprotrusions sized and configured to grab and anchor to tissue with theoutward biasing force. In still another embodiment, the curved externalsurface of the foam anchor portion defines multiple recesses therein,the multiple recesses defined by raised portions of the curved externalsurface of the foam anchor portion. In another embodiment, the curvedexternal surface of the foam anchor portion defines multiple ring shapedstructures.

In still another embodiment, the foam anchor portion extends with avariable foam density between a proximal end portion and a distal endportion of the foam anchor portion, the distal end portion having agreater foam density than the proximal end portion. In anotherembodiment, the foam anchor portion includes variable expandabilitybetween a proximal end portion and a distal end portion of the foamanchor portion, the distal end portion having greater expandability thanthe proximal end portion.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing and other advantages of the invention will become apparentupon reading the following detailed description and upon reference tothe drawings in which:

FIG. 1 is a perspective rear view of a medical device, according to oneembodiment of the present invention;

FIG. 2 is a perspective front view of the medical device, according toanother embodiment of the present invention;

FIG. 3 is a side view of the medical device, according to anotherembodiment of the present invention;

FIG. 4 is a perspective view of a delivery system for the medicaldevice, according to another embodiment of the present invention;

FIG. 5 is a side view of a distal portion of the delivery system,depicting a distal portion of the delivery system adjacent a left atrialappendage of a heart, according to another embodiment of the presentinvention;

FIG. 6 is a side view of the distal portion of the delivery system,depicting the medical device being partially advanced from the distalportion of the delivery system in the left atrial appendage, accordingto another embodiment of the present invention;

FIG. 7 is a side view of the distal portion of the delivery system,depicting an anchor portion of the medical device in an expanded statein the left atrial appendage, according to another embodiment of thepresent invention;

FIG. 8 is a side view of the distal portion of the delivery system,depicting a cover portion of the medical device being partially advancedfrom the distal portion of the delivery system adjacent the left atrialappendage;

FIG. 9 is a side view of the distal portion of the delivery system andmedical device, depicting the cover portion fully expanded with thedelivery system coupled to the medical device with a flexible member,according to another embodiment of the present invention;

FIG. 10 is a side view of the distal portion of the delivery system andmedical device, depicting the distal portion of the delivery systemcinching the cover portion against the left atrial appendage with theflexible member, according to another embodiment of the presentinvention;

FIG. 11 is a side view of the distal portion of the delivery system andmedical device, depicting the anchor portion anchoring the medicaldevice in the left atrial appendage with the cover portion positionedover an ostium of the left atrial appendage, according to anotherembodiment of the present invention;

FIG. 12 is a perspective view of another embodiment of a medical device,depicting the anchor portion having a truncated cone structure withmultiple recesses defined in an external surface of the anchor portion,according to the present invention.

FIG. 13 is a side view of the medical device of FIG. 12, according toanother embodiment of the present invention;

FIG. 14 is a perspective view of another embodiment of a medical device,depicting the anchor portion having a cylindrical structure and thecover portion extending with a disc structure, according to the presentinvention;

FIG. 15 is a side view of the medical device of FIG. 14, according toanother embodiment of the present invention;

FIG. 16 is a perspective view of another embodiment of a medical device,depicting the anchor portion having a cylindrical structure with nubprotrusions along an external surface of the anchor portion, accordingto the present invention;

FIG. 17 is a side view of the medical device of FIG. 16, according toanother embodiment of the present invention;

FIG. 18 is a perspective view of another embodiment of a medical device,depicting the anchor portion having a cylindrical structure with a ringconfiguration over an external surface of the anchor portion, accordingto the present invention; and

FIG. 19 is a side view of the medical device of FIG. 18, according toanother embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1, 2 and 3, a medical device 10 sized and configuredto be percutaneously delivered with a delivery system 80 (FIG. 4)through the cardiovascular system is provided. The medical device 10 andthe delivery system 80 may be employed in interventional procedures forclosing or occluding an opening or cavity such as, for example, a leftatrial appendage (“LAA”) within a heart (not shown). In one embodiment,the medical device may include a cover portion 14 and an anchor portion16 with a flexible member 18 coupled therebetween. The anchor portion 16of the medical device 10 may be sized to self-expand so as to lodgewithin the left atrial appendage in an atraumatic manner without hooksor tines to minimize perfusions that may otherwise occur from anchoringin the left atrial appendage. Such atraumatic anchoring of the medicaldevice 10 may be employed with an outward biasing force of the anchorportion 16 such that an external surface 34 of the anchor portion, alongopposing external surfaces 34 of the anchor portion 16, maintainscontact with tissue within the left atrial appendage. In this manner,the body and external surface 34 of the anchor portion 16 of the medicaldevice 10 may be sized to provide a self-expanding and biasing force 17(FIG. 7) to lodge itself atraumatically against tissue within the leftatrial appendage.

As previously set forth, the medical device 10 may include the coverportion 14 and the anchor portion 16 with the flexible member 18extending therebetween. The medical device 10 may extend between aproximal end 20 and a distal end 22 along a length 24 of the medicaldevice 10 and may define an axis 26 extending longitudinally through themedical device and through each of the cover portion 14 and anchorportion 16 along the length 24 of the medical device 10. The medicaldevice 10 may include structural components that self-expand from aconstricted state within, for example, a distal end portion 84 of acatheter 82 (see FIGS. 4 and 5) to an expanded state (e.g., FIG. 1).

For example, in one embodiment, the anchor portion 16 may be formed froma foam material extending between an anchor proximal end 36 and thedistal end 22 of the medical device 10. In the expanded state, the foammaterial may be sized to extend in a trapezoidal cylinder or truncatedcone structure or the like. Such structure may be oriented so that theanchor portion 16 extends radially larger toward the distal end 22.Further, along the length of the anchor portion 16, the external surface34 of the anchor portion 16 may extend radially or with a curved orarcuate surface relative to the axis 26 between the anchor proximal end36 and the distal end 22. In one embodiment, the distal end 22 of theanchor portion 16 may be a generally flat surface extending to acircular periphery 38 so as to define a distal end radius 40 relative tothe longitudinal axis 26. Similarly, the anchor proximal end 36 may be agenerally flat surface extending to a circular periphery to define aproximal end radius 42 relative to the longitudinal axis 26. In anotherembodiment, a distal side surface 44 and/or a proximal side surface 46of the anchor portion 16 may extend with a convex surface or concavesurface extending radially relative to the longitudinal axis 26.

As previously set forth, the anchor portion 16 may be formed from a foammaterial. The foam may be of a structural characteristic that can beconstricted and minimized in size such as within the lumen of thecatheter 82 (FIG. 4) and, upon being advanced from the catheter 82, thefoam may self-expand in an immediate manner. In one embodiment, the foamof the anchor portion 16 may self-expand isotropically. In anotherembodiment, the foam may self-expand in an anisotropic manner. Inanother embodiment, the foam may expand with a greater degree toward thedistal end 22 of the anchor portion 16 than toward the anchor proximalend 36. In another embodiment, the foam may expand with a greaterexpanding force along a distal portion of the anchor portion 16 thanthat of a more proximal portion of the anchor portion 16. In anotherembodiment, the foam may define pores or a porosity size therein. Theporosity size of the foam of the anchor portion 16 may be in the rangeof about 300 to 600 microns, and preferably about 500 microns.

In still another embodiment, the foam material may be generallyhomogeneous in density. In another embodiment, the foam material mayinclude a variable density along the length thereof. For example, thevariable density may progressively be more dense from the anchorproximal end 36 toward the distal end 22 of the anchor portion 16. Inanother embodiment, the variable density may progressively be denserfrom the distal end 22 toward the anchor proximal end 36. In anotherembodiment, the density of the foam material of the anchor portion 16may be variable in that portions of the anchor portion 16 may exhibitdifferent densities. Such different densities of the foam material maybe, for example, in two parts or three parts of the anchor portion 16.For example, the variable density foam material may be divided with aproximal anchor portion and a distal anchor portion, the distal anchorportion being denser than the proximal anchor portion. In an alternateembodiment, the variable density foam material may be divided with aproximal anchor portion, an intermediate anchor portion, and a distalanchor portion, the intermediate and distal anchor portions being denserthan the proximal anchor portion and the distal anchor portion beingdenser than the intermediate anchor portion. In another embodiment, theproximal portion of the anchor portion 16 may be more dense than theintermediate anchor portion or the distal anchor portion. In thismanner, there are multiple embodiments as to the foam materialexhibiting a variable density along the length of the anchor portion 16.

Further, in another embodiment, the external surface 34 of the anchorportion 16 and foam material may be non-smooth or somewhat variable andinconsistent such that the external surface 34 may define microprotrusions 35 along a periphery of the external surface 34 such thatthe micro protrusions 35 may be slightly raised relative to surroundingportions of the external surface 34. In one embodiment, the microprotrusions 35 may be random and an inherent characteristic of theexternal surface 34 of the foam material such that the micro protrusions35 may assist in grabbing onto tissue within the left atrial appendage.In another embodiment, the micro protrusions 35 may be formed and spaceda pre-determined distance relative to each other over the externalsurface 34 of the foam. In another embodiment, the micro protrusions 35may include hardened tips such that the micro protrusions 35 exhibiteffective micro tines sized and configured to grab tissue.

The foam material of the anchor portion 16 may be formed from apolymeric foam material. The polymeric foam material may be apolyurethane foam material or any other suitable foam material, such asa polyurethane blend, such as polycaprolactane-zinc-oxide. In anotherembodiment, the polymeric foam may be hydrophilic. In anotherembodiment, the foam may be reticulated foam. In another embodiment, thefoam may be a non-reticulated foam. In another embodiment, the anchorportion may include other polymeric materials, such as ePTFE and/orsilicone.

Further, in another embodiment, the polymeric foam may include multiplemarkers (not shown) embedded therein. Such markers may be positionedwithin the foam material to assist the physician to appropriately orientand position the anchor portion 16 in the left atrial appendage byemploying imaging techniques, as known in the art. The markers may bemade from a radiopaque material, such as platinum, gold, tantalum, oralloys thereof, or any other suitable radiopaque materials that arebiocompatible.

The cover portion 14 of the medical device 10 may include a framestructure 48 and a cover 50. The frame structure 48 of the cover portion14 may include a hub 52, spokes 54 and a lip portion 56. The framestructure 48 may be formed from super elastic materials, such as Nitinoland/or polymeric materials. The spokes 54 may extend radially from thehub 52 to the lip portion 56. The frame structure 48 may support thecover 50 such that the cover 50 may extend along at least a proximalside 57 of the frame structure 48. The cover portion 14 may extend witha disc like structure to define the proximal side 57 and a distal side58 of the cover portion 14. The proximal side 57 may extend with aconcave structure. The distal side 58 may generally extend with a convexstructure. Such concave structure of the proximal side 57 of the coverportion 14 may be at least partially formed with the spokes 54 of theframe structure 48. The spokes 54 may extend from the hub 52 so as toextend radially and slightly proximally to spoke end portions 60. At thespoke end portions 60, the spokes 54 may include a bend or curvedportion 62 so that the spokes 54 curve to extend more proximally tospoke ends 64. Such spoke end portions 60 and/or curved portions 62 ofthe spokes 54 may at least partially form the concave structure of theproximal side 57 of the cover portion 14 and, further, the spoke endportions 60 may at least partially form the lip portion 56 of the coverportion 14. The lip portion 56 may define an outer lip 66 and an innerlip 68. The outer lip 66 may extend radially with a ring structure andmay be positioned more proximal than the inner lip 68. The inner lip 68may extend radially and more distal than the outer lip 66 such that theinner lip 68 may extend smaller or with a smaller radius than the outerlip 66 so that an external profile of the outer lip 66 exhibits a distalstep inward relative to the outer lip 66 and the axis 26 of the medicaldevice 10. The spoke end portions 60 may extend along an externalsurface of the inner lip 68 with the spoke ends 64 positioned within oradjacent the outer lip 66 of the lip portion 56. In this manner, thespokes 54 of the frame structure 48 may support the lip portion 56 andthe cover 50 of the cover portion 14.

The frame structure 48 of the cover portion 14 may be sized andconfigured to self-expand from the constricted state to the expandedstate. The cover portion 14 may be constricted in the distal end portion104 of the catheter 82 such that the spokes 54 of the frame structure 48may fold inward so as to extend and fold proximally from the hub 52. Inthis position, the spokes 54 may extend generally parallel within thecatheter 82. Upon being advanced from the distal end portion 84 of thecatheter 82, the spokes 54 may be biased to self-expand to a radiallyextending expanded position such that the cover portion 14 may expandthe lip portion 56 and cover 50. Further, in one embodiment, the spokes54 may be designed to expand independently relative to each other suchthat the spokes 54 may not be interconnected to each other, exceptadjacent the hub 52 and via the cover 50 or lip portion 56. Suchindependent expansion of the spokes 54 may better facilitate the spokesbiasingly conforming to the wide variety of ostium shapes of the leftatrial appendage. In another embodiment, the spokes 54 may interconnectwith adjacently extending spokes 54 at one or more positions along alength of a given spoke. Such interconnection may keep any one spokefrom tangling with another spoke as the cover portion is moved betweenthe expanded and constricted positions, as set forth above.

The cover 50 of the cover portion 14 may be a material sized andconfigured to induce tissue ingrowth therein and over the cover 50. Aspreviously set forth, the cover 50 may extend at least along theproximal side 57 of the frame structure 48 and cover portion 14. In oneembodiment, the cover may me formed of a polymeric type material, suchas expanded polytetrafluoroethylene (ePTFE), or any other suitablepolymeric material configured to induce tissue growth. For example, thecover 50 may include multiple layers of a polymeric material, such asthe ePTFE, such as two to six layers or more. The multiple layers of thecover may be formed by bonding the layers together, such as withadhesives and/or thermal bonding heat processes or other appropriateprocesses known in the art. Further, the cover 50 may be adhesivelyattached to the proximal side 57 of the frame structure 48, or the cover50 may be attached to the frame structure 48 with any other suitabletechnique or means for attaching to the frame structure 48, such as withheat bonding techniques. In another embodiment, the material of thecover 50 may define pores or porosity therein, the pores sized withinthe range of about 50 microns to about 200 microns.

Further, the cover 50 may extend with the spoke end portions 60 to formthe inner lip 68 such that the cover 50 may be adhesively attached tospoke end portions 60 to form inner lip 68. The outer lip 66 may beadhesively attached to the inner lip 68 of the cover 50 and may extendradially in the ring like structure so as to be supported with the spokeends 64 of the frame structure 48 and be contiguous with the cover 50.The outer lip 66 of the lip portion 56 may be a resilient polymericmaterial, such as foam or ePTFE, or any other suitable polymericmaterial. In another embodiment, the outer lip 66 may be a continuousextension of the cover 50. With this arrangement, the lip portion 56 maybe sized and configured to nest in a soft conforming manner along anouter or front side of a periphery of an ostium of a left atrialappendage. In one embodiment, the lip portion 56 may be biased toself-expand to the ring shaped structure. In another embodiment, the lipportion 56 may expand to the ring shaped structure via the framestructure 48 being moveable and biased to a radially expanded position.Further, the lip portion 56 may be sized and configured to becollapsible in a minimized manner with the entire cover portion toreadily fit within the catheter 82 (FIG. 4). Furthermore, similar to theanchor portion 16, the cover portion 14 may include markers. The markersmay be positioned along the lip portion 56 and/or the along the spokes54 of the cover portion 14. Such markers may be formed of radiopaquematerial, such as platinum, gold, tantalum, or alloys thereof, or anyother suitable radiopaque material, so that the physician may readilyview the orientation and positioning of the cover portion 14 and themedical device 10 relative to the left atrial appendage by employingvarious imaging techniques, as known in the art.

As previously set forth, the flexible member 18 may extend between thecover portion 14 and the anchor portion 16 of the medical device 10. Theflexible member 18 may be an elongated flexible filament type structurethat couples the anchor portion 16 to the cover portion 14 of themedical device 10. In the drawing figures, the flexible member 18 isdepicted in a tension state, such that in one embodiment, the flexiblemember 18 may be of the type that does not provide an appreciablecompressive force and, if not in the tension state, the flexible member18 would move to a limp position. The flexibility of the flexible member18 may facilitate orienting the cover portion 14 relative to the anchorportion 16 so that the medical device 10 may conform to the particularanatomy of a given left atrial appendage, for example.

In one embodiment, the flexible member 18 may extend between an anchorhub 70 and the hub 52 of the cover portion 14 such that a portion of theflexible member 18 may be coupled to the hub 52 of the cover portion 14.The flexible member 18, in a pre-released position of the medical device10 relative to the delivery system 80, may continue proximally from thehub 52 and be operatively coupled to the handle 108 of the deliverysystem 80. At the anchor hub 70, the flexible member 18 may be coupledto the anchor hub 70 such that the anchor hub 70 may include couplingstructure 72 for maintaining the anchor hub 70 to the anchor portion 16.Such coupling structure 72 may include extensions 74 extending laterallyrelative to the axis 26. In another embodiment, the flexible member 18may include structure extending directly therefrom that may extendwithin the anchor portion 16 so as to extend laterally relative to thelongitudinal axis 26 of the anchor portion 16 to hold the flexiblemember 18 to the anchor portion 16.

With reference to FIGS. 3 and 4, a delivery system 80 for delivering themedical device 10 (shown in outline in FIG. 4) to, for example, the leftatrial appendage is provided. As previously set forth, the medicaldevice 10 may be coupled to the delivery system 82 with the flexiblemember 18 or another flexible element. In addition, the medical device10, in the constricted state, may be maintained in the distal endportion 84 of the catheter 82 of the delivery system 80 with aninterference type fit. The primary components of the delivery system 80may include the catheter 82 fixedly coupled to a handle 86. Further, thedelivery system 80 may be sized and configured to cooperate with asheath system 90. The sheath system 90 may be a standard sheath systemsized and configured to advance over a guide wire (not shown) throughthe cardio vascular system. In one embodiment, the sheath system 90 mayinclude a sheath hub 92 and a sheath 94, the sheath hub 92 positionedand coupled to a proximal end of the sheath 94. The sheath system 90 mayalso include a sheath fluid port 96 sized and configured to feed fluidto a lumen of the sheath 94. Such lumen of the sheath 94 may be sizedand configured to receive and advance the catheter 82 of the deliverysystem 80 therethrough, upon the sheath 94 being advanced to a desiredlocation within the cardio vascular system, such as to the left atrialappendage of the heart.

The catheter 82 may define a lumen extending along a length of thecatheter and extending along a catheter longitudinal axis 98 between aproximal end 102 and a distal end 104, the proximal end 102 coupled tothe handle 86. The handle 86 may include a switch 106 and a push rod108, the push rod 108 extending from a proximal end of the handle 86.The push rod 108 may include a knob 112 at a proximal end of the pushrod 108 and a distal pusher portion 110 (FIG. 5) at a distal end of thepush rod 108. Further, a portion of the push rod 108 may be a tubularcoil (not shown) extending within the lumen of the catheter 82 to thedistal pusher portion 110 of the push rod 108, the tubular coil defininga lumen sized and configured to hold a portion of the flexible member 18(FIG. 1). The knob 112 may be fixed to the proximal end of the push rod108 and may be sized and configured for a physician to readily grasp andmove the push rod bi-linearly, as shown by bi-directional arrow 114,and/or the knob 112 may be moveable rotationally, as shown by rotationalarrow 116. For example, the push rod 108 may be moved distally fordeploying the medical device 10 from the distal end portion 84 of thecatheter 82 and the push rod 108 may be moved proximally forre-capturing the medical device 10 into the distal end portion 84 of thecatheter 82. Further, the knob 112 may be rotatable for releasing themedical device 10 from the delivery system 80, for example. In anotherembodiment, the switch 106 may be moved to multiple positions to controldisplacement of the push rod 108 while, for example, deploying themedical device 10 or re-capturing the medical device 10. In addition,the delivery system 80 may include a fluid port 118 associated with thehandle 86 to advance fluid to the lumen of the catheter 82. Furtherdetail and functionality of the various components of the deliverysystem 80 will be described in conjunction with description ofdelivering the medical device 10 with the delivery system 80 in the leftatrial appendage.

Now with reference to FIGS. 4-11, one embodiment for delivering themedical device 10 with the delivery system 80 to a left atrial appendage5 of a heart will now be described. With reference to FIGS. 4 and 5, themedical device 10 may be pre-positioned or prepared for positioningwithin the distal end portion 84 of the catheter 82. Upon the medicaldevice 10 being positioned adjacent the distal end portion 84 of thecatheter 82, the physician may make preparations for positioning adistal end 120 of the sheath 94 adjacent the left atrial appendage 5.Such may be employed by using typical interventional techniques with,for example, a guide wire and a sheath, as known in the art. Once thesheath 94 has been appropriately advanced adjacent to the left atrialappendage 5, the catheter 82 of the delivery system 80 may be advancedthrough the sheath 94 so that the distal end portion 84 of the catheter82 is positioned adjacent the left atrial appendage 5. Once positioned,the sheath 94 may be fully or slightly withdrawn from the distal endportion 84 of the catheter 82 so that the distal end portion 84 may bepositioned within the left atrial appendage 5, as depicted in FIG. 5.

With reference to FIGS. 4-7, once the physician is satisfied with theposition of the distal end portion 84 of the catheter 82, the physicianmay advance the anchor portion 16 into the left atrial appendage 5 withthe push rod 108 actuatable at the handle 86. The push rod 108 mayextend from the knob 112 and continue distally through the handle andthe lumen of the catheter 82 to just proximal and adjacent the medicaldevice 10 at the distal end portion 84 of the catheter 82. The physicianmay move the push rod 108 distally to a first hard stop to deploy theanchor portion 16 of the medical device 10 by moving the knob 112distally, as shown by bi-directional arrow 114. As the knob 112 and pushrod 108 are moved distally, the distal pusher portion 110 of the pushmember 108 may push the medical device 10 from the distal end 104 of thecatheter 82 such that the anchor portion 16 advances from the catheter82. As the anchor portion 16 proceeds from the catheter 82, thestructural characteristics of the anchor portion 16 may effect immediateexpansion so as to self-expand, as depicted in FIGS. 6 and 7.

Because the anchor portion may be sized and configured to be larger thanthe left atrial appendage 5, a majority of the external surface 34 ofthe anchor portion 16 may self-expand and bias against tissue 7 with anoutward biasing force 17 within the left atrial appendage 5 such thatopposing surfaces or sides along the periphery of the external surface34 maintain contact with tissue in the left atrial appendage 5. Further,the curved external surface 34 may bias against tissue with the outwardbiasing force 17 along a circumferential surface area of the anchorportion, defined by a banded length 75 that may extend about a peripheryor circumference of the anchor portion 16, as depicted in FIG. 7. Thebanded length 75 of the anchor portion 16 in biasing contact with thetissue 7 in the left atrial appendage 5 defines a banded portion orcircumferential surface area of the external surface 34 of the anchorportion 16 in biasing contact with the tissue 7 such that opposingsurfaces of the anchor portion 16 plug the left atrial appendage 5.Depending on the size of the anchor portion 16 or left atrial appendage5, the banded length 75 may extend further, such as a full length 77 ofthe anchor portion 16, or a shorter length than that depicted. As such,the banded length 75 may be any length along the length 77 of the anchorportion 16, but preferably the banded length 75 is greater than half thelength 77 of the anchor portion 16. Further, along with the externalsurface 34 of the anchor portion 16 being biased against the tissue 7 inthe left atrial appendage 5, the external surface 34 of the anchorportion 16 may define the micro protrusions 35 (FIG. 1) or otherstructure that may assist in effectively engaging and grabbing tissue tohold the anchor portion 16 in the left atrial appendage 5. In thismanner, the anchor portion 16 may be advanced from the catheter 82 andbecome lodged within the left atrial appendage 5 with the cover portion14 still constricted in the distal end portion 84 of the catheter 82.

With reference to FIGS. 7-9, once the anchor portion 16 is positionedand anchored within the left atrial appendage 5, the physician may, forexample, move or depress the switch 106 to then allow the pusher member108 to move distally to a second hard stop for advancing the coverportion 14 from the distal end portion 84 of the catheter 82. Asdepicted in FIG. 8, the cover portion 14 is shown as being partiallyadvanced from the distal end 104 of the catheter 82. Once the coverportion 14 is fully advanced from the catheter 82, as depicted in FIG.9, the cover portion 14 of the medical device 10 may immediatelyself-expand to either be positioned against or spaced proximally of anostium 9 of the left atrial appendage 5, as depicted. As previously setforth, the cover portion may self-expand via the expansioncharacteristics of the spokes 54 or outer lip 66 of the cover member,for example.

With respect to FIGS. 4, 9, 10 and 11, if the cover portion 14 is aspaced distance from the ostium 9, the physician may cinch the coverportion 14 against the tissue 7 defined by the ostium 9 of the leftatrial appendage 5 via, for example, a slip knot 122 associated with theflexible member 18. The physician may actuate the switch 106 on thehandle 86 and pull the pusher member 108 proximally, as shown with thebi-directional arrow 114. As the physician moves the pusher member 108proximally, the cover portion 14 of the medical device 10 may be cinchedagainst the ostium 9 of the left atrial appendage 5. Through thisprocess, the distal end 104 of the catheter 82 may also push the coverportion 14 against the ostium 9 such that the cover portion 14 ispositioned on an external side of the left atrial appendage 5, oragainst a proximal side of the ostium 9 of the left atrial appendage 5.Once the physician sufficiently cinches the cover portion 14 of themedical device 10 against the ostium 9 in a somewhat sealing manner, theswitch 106 may be actuated so that the knob 112 of the pusher member 108may be rotated, as shown by rotational arrow 116, to release the medicaldevice 10 from the delivery system 80. For example, upon rotating theknob 112, a cutting or slicing mechanism (not shown) may be actuated tocut the flexible member 18 at a point proximal the cover portion 14adjacent the hub 52 (FIG. 2) of the cover portion 14, as depicted inFIG. 11. The physician may then withdraw the catheter 82 from the heartand patient.

In this manner, the delivery system 80 may release the medical device 10within the left atrial appendage 5 of a heart such that the anchorportion 16 may lodge the medical device 10 in the left atrial appendage5 with the cover portion 14 sized and configured to seal and cover theostium 9 of the left atrial appendage 5. Such cover portion 14 may bemaintained against the ostium 9 of the left atrial appendage 5 due tothe outward biasing force 17 of the anchor portion 14 against the tissuewithin the left atrial appendage 5 such that the anchor portion 14maintains contact along opposing surfaces along a periphery of theexternal surface 34 of the anchor portion against the tissue so that theanchor portion 16 remains anchored in the left atrial appendage 5.Further, due to the flexible characteristics of the flexible member 18,the cover portion 14 may be oriented in various positions against theostium 9 of the left atrial appendage 5 such that the flexible member 18may extend tautly at an angle 78 relative to the axis 26 of the anchorportion 16. With this arrangement, the medical device 10 may close-offthe opening of the left atrial appendage 5 in an atraumatic manner dueto the anchor portion being anchored in the left atrial appendage 5without hooks or tines, thereby, preventing perfusions that mayotherwise occur.

With respect to FIGS. 12 and 13, another embodiment of a medical device130 is provided. This embodiment of the medical device 130 may includesimilar structural characteristics of the medical device describedpreviously and may be employed in a similar manner with the deliverysystem 80 (FIG. 4), as previously set forth. The medical device 130 mayinclude an anchor portion 132 and a cover portion 134 with a flexiblemember 136 coupled therebetween, similar to the previous embodiment. Theanchor portion 132 may extend with a truncated cone structure, except inthis embodiment, an external surface 138 of the anchor portion 132 mayextend with a raised grid pattern 140. The raised grid pattern 140 mayextend over a curved portion of the truncated cone structure between aproximal anchor end 142 and distal end 144 of the medical device 130.Such raised grid pattern 140 may be formed integrally with a foammaterial of the anchor portion 132. In one embodiment, the raised gridpattern 140 may be a continuation of the foam material. In anotherembodiment, the raised grid pattern 140 may be another polymericmaterial coupled to an underlining or core portion of the foam materialof the anchor portion 132. As in the previous embodiment, the foammaterial of the anchor portion 132 may include micro protrusions alongthe external surface 138 of the anchor portion 132, including along theraised grid pattern 140. The raised grid pattern 140 of the anchorportion 132 may extend so that, upon being anchored in the left atrialappendage, the raised grid pattern 140 may facilitate grabbing portionsof the external surface 138 in contact with tissue of the left atrialappendage. In this manner, and as in the previous embodiment, the anchorportion 132 with the raised grid pattern 140 may be conformable andresilient so that the anchor portion 132 may effectively be anchoredwithin the left atrial appendage.

With reference to FIGS. 14 and 15, another embodiment of a medicaldevice 150 is provided. Similar to the previous embodiments, the medicaldevice 150 may define an axis 152 with an anchor portion 154 and a coverportion 156 with a flexible member 158 extending therebetween. Theflexible member 158 may include similar structural characteristics asthat described in previous embodiments.

In this embodiment, the anchor portion 154 may be a cylindricalstructure sized and configured to be anchored within a left atrialappendage similar to the previous embodiments. Such cylindricalstructure may be formed of a foam material. The cylindrical structuremay include a length 160 extending between a proximal anchor end 162 anda distal end 164. The cylindrical structure may define an externalsurface 165 extending radially between the proximal anchor end 162 andthe distal end 164 so as to define an anchor portion radius 166 alongthe length 160. As in the previous embodiments, the foam material of theanchor portion 154 may include micro protrusions along the externalsurface 165 of the anchor portion 132 to assist the anchor portion ingrabbing tissue and lodging within the left atrial appendage with theoutward biasing force of the foam material.

The cover portion 156 of this embodiment may be a disc structuredefining a cover portion radius 168. The cover portion radius 168 may beequal to or larger than the anchor portion radius 166. The cover portion156 may include a hub 170, a cover 172 and a lip 174. The hub 170 may bealigned with the flexible member 158 with the cover 172 extendingradially from the hub 170. The lip 174 may extend with a ring shapedstructure and may extend along an outer periphery 176 of the cover 172.The lip 174 and cover 172 may include similar materials as thatdescribed in the previous embodiments. The lip 174 may be sized andconfigured to self-expand from a constricted state to an expanded state,as depicted. In another embodiment, the cover portion 156 may includespokes extending from the hub 170 such that the spokes may extendradially relative from the hub 170 to the lip 174 of the cover portion156. The spokes may operate similar to that described in previousembodiments, providing structural support and self-expandingcharacteristics.

Now with reference to FIGS. 16 and 17, another embodiment of a medicaldevice 180 sized and configured to occlude an opening, such as a leftatrial appendage. The medical device 180 of this embodiment is similarto the previous embodiment, including an anchor portion 182 and a coverportion 184 with a flexible member 186 extending therebetween. In thisembodiment, the anchor portion 182 may include a foam material defininga cylindrical like structure with an external surface 188 extending withmultiple ring shaped structures 189 over the cylindrical structure. Thefoam material of the cylindrical structure and the ring shapedstructures may include, as in previous embodiments, micro protrusionsalong the external surface 188 of the foam material to assist ingrabbing tissue within, for example, the left atrial appendage. The ringshaped structures 189 may extend around the cylindrical structure in anevenly spaced manner. In another embodiment, the ring shaped structures189 may extend around the cylindrical structure adjacently alongsideeach other. In another embodiment, the ring shaped structures 189 mayextend with a gap or spacing between each of the ring shaped structures189. Such ring shaped structures 189 also may assist in grabbing tissuewith the outward biasing force of the foam material. The cover portion184 and flexible member 186 may exhibit similar structuralcharacteristics as described in previous embodiments.

With reference to FIGS. 18 and 19, another embodiment of a medicaldevice 190 is provided. In this embodiment, the medical device 190 maybe substantially similar to the previous embodiment, including an anchorportion 192 and a cover portion 194 with a flexible member 196therebetween. As in the previous embodiments, the anchor portion 192 maybe formed of a foam material that may self-expand and provide theoutward biasing force against tissue in the left atrial appendage. Theanchor portion 192 may include a cylindrical structure, but instead ofring shaped structures, an external surface 198 of the cylindricalstructure may include multiple protrusions 199 or nubs thereon. Theprotrusions 199 may be sized and configured to grab tissue with theoutward biasing force of the anchor portion 192. Further, theprotrusions and portions of the anchor portion surrounding theprotrusions may include micro protrusions to assist in grabbing tissue,as described in previous embodiments. The protrusions 199 may bepositioned in an aligned manner, such as rows, extending along alongitudinal length of the cylindrical structure. In another embodiment,the protrusions 199 may extend from the cylindrical structure in arandom manner or staggered manner.

In another embodiment, the anchor portion of the various embodiments ofthe medical device set forth herein may be employed without the coverportion such that the medical device may act as a stand-alone plug toclose-off the opening of the left atrial appendage. In this embodiment,the anchor portion may include similar structural characteristics asthat described for the anchor portion of the various embodiments herein.Further, the proximal surface of the anchor portion or surface facingthe left atrial chamber may be smooth and may be sized and designed toplug the ostium so that the proximal surface sits adjacent the ostium ofthe left atrial appendage.

While the invention may be susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and have been described in detail herein.However, it should be understood that the invention is not intended tobe limited to the particular forms disclosed. Rather, the inventionincludes incorporating any portion of one embodiment with anotherembodiment, all modifications, equivalents, and alternatives fallingwithin the spirit and scope of the invention as defined by the followingappended claims.

What is claimed is:
 1. A medical device for occluding a left atrial appendage of a heart, comprising: a cover portion having a hub and a cover, the cover extending radially from the hub, the cover portion sized and configured to be positioned along a proximal side of an ostium of the left atrial appendage; and a foam anchor portion coupled to the cover portion with a flexible member, the foam anchor portion extending between a proximal end and a distal end to define a length and an axis defined along the length of the foam anchor portion, the foam anchor portion defining a curved external surface radially extending relative to the axis such that the curved external surface extends between the proximal and distal ends of the foam anchor portion, the proximal end of the foam anchor portion extending to define a first radius and the distal end of the foam anchor portion extending to define a second radius, the second radius being greater than the first radius such that the curved external surface between the distal end and the proximal end extends with a truncated cone shape along an entirety of the length between the distal end and the proximal end, the foam anchor portion extending to define a raised grid pattern, the foam anchor portion configured to self-expand to provide an outward biasing force from the curved external surface such that a circumferential surface area of the curved external surface biases against tissue of the left atrial appendage.
 2. The medical device of claim 1, wherein the curved external surface defines a total surface area, and wherein at least half of the total surface area of the curved external surface is sized and configured to grab and contact tissue within the left atrial appendage.
 3. The medical device of claim 1, wherein the curved external surface of the foam anchor portion comprises micro protrusions sized and configured to grab and contact tissue within the left atrial appendage with the outward biasing force.
 4. The medical device of claim 1, wherein the curved external surface of the foam anchor portion extends with the raised grid pattern and is sized and configured to grab tissue with the outward biasing force.
 5. The medical device of claim 1, wherein the curved external surface of the foam anchor portion defines multiple protrusions sized and configured to grab and anchor to tissue with the outward biasing force.
 6. The medical device of claim 1, wherein the curved external surface of the foam anchor portion defines multiple recesses therein, the multiple recesses defined by the raised grid pattern of the foam anchor portion.
 7. The medical device of claim 1, wherein the curved external surface of the foam anchor portion defines multiple ring shaped structures.
 8. The medical device of claim 1, wherein the foam anchor portion includes variable expandability between a proximal end portion and a distal end portion of the foam anchor portion, the distal end portion having greater foam expandability than the proximal end portion.
 9. The medical device of claim 1, wherein the cover portion extends with a proximal facing surface having a concave structure, the proximal facing surface facing away from a distal end of the medical device.
 10. The medical device of claim 1, wherein, upon the cover portion and the foam anchor portion being deployed, the flexible member is extendable at an angle relative to the axis of the foam anchor member.
 11. A medical device system for occluding a left atrial appendage of a heart, comprising: a delivery device having a handle and a catheter extending between a proximal end and a distal end, the proximal end coupled to the handle, the catheter defining a lumen extending longitudinally through the catheter between the proximal and distal ends of the catheter; and a medical device operatively coupled to the handle, the medical device sized and configured to be moved between a constricted state and an expanded state such that, in the constricted state, the medical device is within a distal end portion of the catheter and, in the expanded state, the medical device is advanced from the catheter, the medical device comprising: a cover portion having a hub and a cover, the cover extending radially from the hub, the cover portion sized and configured to be positioned along a proximal side of an ostium of the left atrial appendage; and a foam anchor portion coupled to the cover portion with a flexible member, the foam anchor portion extending between a proximal end and a distal end to define a length and an axis defined along the length of the foam anchor portion, the foam anchor portion defining a curved external surface radially extending relative to the axis such that the curved external surface extends between the proximal and distal end of the foam anchor portion, the proximal end of the foam anchor portion extending to define a first radius and the distal end of the foam anchor portion extending to define a second radius, the second radius being greater than the first radius such that the curved external surface between the distal end and the proximal end extends with a truncated cone shape along an entirety of the length between the distal end and the proximal end, the foam anchor portion extending to define a raised grid pattern, the foam anchor portion configured to self-expand to provide an outward biasing force from the curved external surface such that a circumferential surface area of the curved external surface biases against tissue of the left atrial appendage.
 12. The medical device system of claim 11, wherein the curved external surface defines a total surface area, and wherein at least half of the surface area of the curved external surface is sized and configured to grab and contact tissue within the left atrial appendage with the outward biasing force.
 13. The medical device system of claim 11, wherein the curved external surface of the foam anchor portion comprises micro protrusions sized and configured to grab and contact tissue within the left atrial appendage with the outward biasing force.
 14. The medical device system of claim 11, wherein, upon the cover portion and the foam anchor portion being deployed, the flexible member is extendable at an angle relative to the axis of the foam anchor member.
 15. The medical device of claim 11, wherein the curved external surface of the foam anchor portion extends with the raised grid pattern and is sized and configured to grab tissue with the outward biasing force.
 16. The medical device system of claim 11, wherein the curved external surface of the foam anchor portion defines multiple recesses therein, the multiple recesses defined by the raised grid pattern of the foam anchor portion.
 17. The medical device system of claim 11, wherein the curved external surface of the foam anchor portion comprises multiple ring shaped structures.
 18. The medical device system of claim 11, wherein the foam anchor portion includes variable expandability between a proximal end portion and a distal end portion of the foam anchor portion, the distal end portion having greater foam expandability than the proximal end portion.
 19. The medical device system of claim 11, wherein the cover portion extends with a proximal facing surface having a concave structure, the proximal facing surface facing away from a distal end of the medical device. 